Effect of local anesthesia in patients with marginal periodontitis undergoing subgingival scaling

INTERVENTION: Product Name: Bupizenge Product Code: BUPI25 Pharmaceutical Form: Lozenge CAS Number: 18010‐40‐7 Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 25‐ Trade Name: Xyloplyin Dental Adrenalin Product Name: Xyloplyin Dental Adrenalin Pharmaceutical Form: Injection CAS Number: 51‐43‐4 Other descriptive name: ADRENALINE Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 12,5‐ Other descriptive name: LIDOCAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: Pain and discomfort during dental treatment in patients with periodontitis ; MedDRA version: 15.1 Level: LLT Classification code 10009102 Term: Chronic periodontitis System Organ Class: 100000004862 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration Primary end point(s): To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration; The patient scores the level of pain by:; ‐Visual Analog Scale (VAS) 0‐10 where 0 = no pain, 10 = extreme pain.; ‐McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile.; The patient scores the level of discomfort by:; ‐Visual Analog Scale (VAS) 0‐10 where 0 = no discomfort, 10 = extreme discomfort. Secondary Objective: The patient evaluates ; ‐ the pharmaceutical form of the two local anesthetic; ‐ the taste and texture of the lozenge; The dentist evaluates the depuration Timepoint(s) of evaluation of this end point: The patient evaluates pain and discomfort before, during and after the depuration by VAS and MPQ.; SECONDARY OUTCOME: Secondary end point(s): The patient evaluates ; ‐ the pharmaceutical form of the two local anesthetic using a questionnaire ; ‐ the taste and texture of the lozenge using a questionnaire ; The dentist evaluates the depuration using a questionnaire Timepoint(s) of evaluation of this end point: ‐ The patient evaluates the pharmaceutical forms after the depuration ; ‐ The patient assesses taste and texture of the lozenge after the depuration ; ‐ The dentist evaluates the depuration after the procedure INCLUSION CRITERIA: ‐ Patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe ‐ Age between 18 and 80 years ‐ Ability to speak, read and understand danish ‐ Ability to give oral and written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20